MAUDE Adverse Event Report: ANIMAS LLC ANIMAS VIBE; INSULIN INFUSION PUMP

Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Moisture Damage (1405)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.
Event or Problem Description
On (b)(6) 2018, the reporter contacted animas, alleging a power (moisture ingress) issue.The reporter alleged moisture was located behind the display.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 14-jun-2018 with the following findings: during investigation, evidence of moisture was found behind the display lens.The pump powered up with the returned battery cap.The battery cap measured within specifications.The battery cap was able to fully tighten.No battery compartment cracks were observed.No evidence of moisture contamination was found inside the battery compartment.A 24 hour basal program was run with the returned battery cap.No reboots, power losses, or call service alarms were duplicated.A leak test showed a leak at the cover crack.The pump case was removed to find evidence of moisture contamination throughout the inside of the pump.The alleged intermittent power event was not duplicated during the investigation.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7569886
• Report Number: 2531779-2018-10233
• Device Sequence Number: 13497224
• Product Code: OYC
• UDI-Device Identifier: 10840406100532
• UDI-Public: 10840406100532
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 19 MO
• Initial Date Received by Manufacturer: 05/26/2018
• Supplement Date Received by Manufacturer: 05/26/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 33